Why the FDA's Move to Restrict ECT Should Alarm Us All
Should science or propaganda drive medical policy?
Posted Jan 29, 2016
It’s been almost exactly five years since I drove down to Washington, D.C. in the middle of a blizzard – not as bad as the one that hit the East Coast last weekend, but bad enough to stretch a typical two-and-a-half hour drive into an eight-hour crawl. I went to testify in front of the Neurological Devices Panel of the FDA’s Medical Devices Advisory Committee, to argue that electroconvulsive therapy (ECT) – the only treatment that had successfully stopped the aggressive and self-injurious behaviors that threatened to land my autistic son, Jonah, in a locked ward, possibly for the rest of his life – should be made more accessible to patients who need it. At issue was whether ECT machines should be moved from Class III, the most restricted category of medical devices, to Class II.
For five years, the FDA failed to act on the recommendations of the panel, or even respond in any way. Then, this past December, it finally proposed a rule: “Reclassify the electroconvulsive (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition…into class II.”
Although this was not at all the recommendation of the original panel – which also proposed reclassifying ECT devices for only one indication, catatonia, a potentially fatal motor syndrome that doesn’t appear at all in the proposal as it now stands – the rule looks, at first, like a win for ECT advocates. By moving ECT devices into Class II, device manufacturers won’t be required to submit the extensive (and prohibitively expensive) documentation required to file a premarket approval application (PMA), which is required of Class III devices. And the indication included, major depression, is the most common for which ECT is prescribed.
But the rule, if implemented, could potentially have a “chilling effect” on ECT accessibility, according to Dr. Charles Kellner, the director of the ECT service at Mt. Sinai Hospital, the leader of the Consortium for Research in ECT (CORE), and Jonah’s first ECT provider, who explained to me the implications of this very complicated proposal and its accompanying 27-page guidance document.
“The biggest problem is the restriction to one very narrow indication,” he told me. “That leaves out everything else: schizophrenia, schizoaffective disorder, mania and catatonia.” It also leaves out developmentally disabled kids with dangerous behaviors like Jonah. All told, Dr. Kellner estimates that as many as 40% of the 100,000 Americans who get ECT every year could lose their access to this life-saving treatment if patients’ insurance companies exclude off-label use of ECT, malpractice insurance companies refuse to cover doctors who provide it, or hospital administrators prohibit their ECT providers from administering it – all possible outcomes if the FDA rule goes into effect.
Even depressed patients would still be at risk. “The rule also precludes maintenance ECT treatment,” Dr. Kellner added. While some patients manage their illnesses with medication, cognitive behavior therapy or other strategies following an initial course of ECT, at least 30% rely on maintenance, or periodic, ECT treatments to keep their symptoms from returning. Jonah, for example, needs ECT approximately three times a month to control his agitation, aggression and self-injurious behaviors. If he can’t get ECT – and he fails to meet every criteria in the rule, from age to indication to frequency – we would literally have no choice but to move to Canada. And I doubt we would be the only ones. I know at least twenty other families who could not imagine going back to the days when their autistic children hit themselves in the face so hard and so frequently they detached their own retinas, or attacked caregivers so violently they were left with concussions and broken bones.
So why is the FDA proposing such onerous restrictions on a treatment that it grants in the very same document is powerful enough to help the most ill patients, those “who require a rapid response due to the severity of their psychiatric or medical condition?” Clearly, the argument is not that ECT doesn’t work. In fact, ECT has been thoroughly researched for more than half a century, with over 10,000 citations on pubmed documenting its efficacy treating not only major depression, but the other indications Dr. Kellner listed.
If the FDA isn’t motivated by concerns about ECT’s efficacy, could it be motivated by safety? The Church of Scientology, for example, has long maintained that ECT causes catastrophic loss of personality, memory and cognitive functioning.
But “ECT is the safest procedure that’s done under general anesthesia,” Dr. Kellner told me. “The side effects – which include headache, nausea, and short-term memory loss – are well known and fully explained to potential patients during an involved and comprehensive consent process.” The long-term safety of the procedure has been demonstrated in thousands of studies. To suggest otherwise is to posit a worldwide conspiracy implicating doctors in the U.S., the Netherlands, France, Japan, Israel, Iran, and Spain – to name just a few of the countries publishing research on ECT.
Then why? Surely the FDA isn’t giving Scientology and other anti-psychiatry propaganda the same weight as peer-reviewed studies as it crafts medical policy?
The truth is, nobody knows exactly how the FDA will make its decision – the process so far has hardly been transparent. But the agency is taking public comments here through March 28. Comments need only be a sentence or two, attributed or anonymous. If you believe that ECT should be accessible to patients who need it to treat any of the conditions for which it has been shown to be therapeutic, please let the FDA know. Perhaps you’ve benefited from ECT, or know someone who has. But even if you don’t have even the slightest, most indirect connection to anyone who has ever gotten ECT; even if you’re not particularly interested in reading about how it has transformed Jonah, or its impact on a larger population of developmentally disabled and neurotypical kids with acute psychiatric disorders; even if the testimonials of ECT patients like Carrie Fisher, Kitty Dukakis, National Book Award winner and surgeon Sherwin B. Nuland and novelist Donald Antrim strike you as tangential to your own life – even if all this is true, the FDA proposal to restrict ECT should still concern you. Because what this debate ultimately boils down to is the right of patients and their families to choose without groundless government intervention. We all deserve access to the largest arsenal of evidence-based treatments possible when we, or those we love, are suffering.